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The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dosed H1 antihistamine treatment.
The trial incorporated a Type I error control plan, as follows:
The testing of the primary endpoint was conducted in the following hierarchical order. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.
A hierarchical analysis of the secondary endpoints was performed for each dose found to be significant in the primary endpoint. A p-value that is less than 0.05 can only be claimed statistically significant if statistical significance has been claimed at the previous stage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Experimental | Placebo subcutaneously (sc) every 4 weeks |
|
| Omalizumab 75 mg | Experimental | Omalizumab 75 mg sc every 4 weeks |
|
| Omalizumab 150 mg | Experimental | Omalizumab 150 mg sc every 4 weeks |
|
| Omalizumab 300 mg | Experimental | Omalizumab 300 mg sc every 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo was supplied lyophilized in vials. |
| |
| Omalizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Itch Severity Score at Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12 | The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin E Rosén, MD, PhD | Genentech, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Jolla | California | 92037 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39193419 | Derived | Casale TB, Trzaskoma B, Holden M, Bernstein JA, Maurer M. Does angioedema in patients with chronic spontaneous urticaria impact response to omalizumab? World Allergy Organ J. 2024 Aug 5;17(8):100943. doi: 10.1016/j.waojou.2024.100943. eCollection 2024 Aug. | |
| 29655772 | Derived | Ferrer M, Gimenez-Arnau A, Saldana D, Janssens N, Balp MM, Khalil S, Risson V. Predicting Chronic Spontaneous Urticaria Symptom Return After Omalizumab Treatment Discontinuation: Exploratory Analysis. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1191-1197.e5. doi: 10.1016/j.jaip.2018.04.003. Epub 2018 Apr 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo subcutaneously (sc) every 4 weeks. |
| FG001 | Omalizumab 75 mg | Omalizumab 75 mg sc every 4 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
Omalizumab was supplied lyophilized in vials. |
|
|
| Baseline, Week 12 |
| Change From Baseline in the Weekly Number of Hives Score at Week 12 | The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. | Baseline, Week 12 |
| Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved. | by Week 12 |
| Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12 | The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement. | Week 12 |
| Percentage of Weekly Itch Severity Score MID Responders at Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline. | Baseline, Week 12 |
| Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 | The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size. | Baseline, Week 12 |
| Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12 | The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement. | Baseline, Week 12 |
| Percentage of Angioedema-free Days From Week 4 to Week 12 | The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit. | Week 4 to Week 12 |
| Los Angeles |
| California |
| 90045 |
| United States |
| Redwood City | California | 94063 | United States |
| Walnut Creek | California | 94598 | United States |
| Denver | Colorado | 80206 | United States |
| Miami | Florida | 33173 | United States |
| Savannah | Georgia | 31405 | United States |
| Woodstock | Georgia | 30188 | United States |
| Shiloh | Illinois | 62269 | United States |
| Indianapolis | Indiana | 46256 | United States |
| Overland Park | Kansas | 66210 | United States |
| Baltimore | Maryland | 21237 | United States |
| Wheaton | Maryland | 20902 | United States |
| Ypsilanti | Michigan | 48197 | United States |
| Omaha | Nebraska | 68130 | United States |
| Omaha | Nebraska | 68131 | United States |
| Brick | New Jersey | 08724 | United States |
| Bayside | New York | 11361 | United States |
| Brooklyn | New York | 11203 | United States |
| North Syracuse | New York | 13212 | United States |
| Rochester | New York | 14642 | United States |
| Rockville Centre | New York | 11570 | United States |
| The Bronx | New York | 10461 | United States |
| Asheville | North Carolina | 28801 | United States |
| Canton | Ohio | 44718 | United States |
| Cincinnati | Ohio | 45231 | United States |
| Philadelphia | Pennsylvania | 19140 | United States |
| Pittsburgh | Pennsylvania | 15213 | United States |
| Pittsburgh | Pennsylvania | 15241 | United States |
| Providence | Rhode Island | 02906 | United States |
| El Paso | Texas | 79903 | United States |
| Sandy City | Utah | 84070 | United States |
| Seattle | Washington | 98105 | United States |
| Spokane | Washington | 99204 | United States |
| Madison | Wisconsin | 53715 | United States |
| Milwaukee | Wisconsin | 53226 | United States |
| Aarhus | 8000 | Denmark |
| Copenhagen | 2900 | Denmark |
| Montpellier | 34295 | France |
| Nice | 06200 | France |
| Paris | 75475 | France |
| Bonn | 53127 | Germany |
| Hanover | 30449 | Germany |
| Leipzig | D-'04103 | Germany |
| Mainz | 55131 | Germany |
| München | 80802 | Germany |
| Münster | 48149 | Germany |
| Genova | 16132 | Italy |
| Milan | 20122 | Italy |
| Milan | 20132 | Italy |
| Gdansk | 80-211 | Poland |
| Krakow | 31-913 | Poland |
| Lodz | 90-265 | Poland |
| Warsaw | 02-256 | Poland |
| Wroclaw | 54-239 | Poland |
| Barcelona | 08003 | Spain |
| Madrid | 28041 | Spain |
| Ankara | 06100 | Turkey (Türkiye) |
| Istanbul | 34372 | Turkey (Türkiye) |
| Izmir | 35100 | Turkey (Türkiye) |
| Kayseri | 38039 | Turkey (Türkiye) |
| 28390587 | Derived | Goldstein S, Gabriel S, Kianifard F, Ortiz B, Skoner DP. Clinical features of adolescents with chronic idiopathic or spontaneous urticaria: Review of omalizumab clinical trials. Ann Allergy Asthma Immunol. 2017 Apr;118(4):500-504. doi: 10.1016/j.anai.2017.02.003. |
| 27939380 | Derived | Saini SS, Omachi TA, Trzaskoma B, Hulter HN, Rosen K, Sterba PM, Courneya JP, Lackey A, Chen H. Effect of Omalizumab on Blood Basophil Counts in Patients with Chronic Idiopathic/Spontaneous Urticaria. J Invest Dermatol. 2017 Apr;137(4):958-961. doi: 10.1016/j.jid.2016.11.025. Epub 2016 Dec 6. No abstract available. |
| 27540466 | Derived | Gimenez-Arnau AM, Spector S, Antonova E, Trzaskoma B, Rosen K, Omachi TA, Stull D, Balp MM, Murphy T. Improvement of sleep in patients with chronic idiopathic/spontaneous urticaria treated with omalizumab: results of three randomized, double-blind, placebo-controlled studies. Clin Transl Allergy. 2016 Aug 18;6:32. doi: 10.1186/s13601-016-0120-0. eCollection 2016. |
| 27424128 | Derived | Zazzali JL, Kaplan A, Maurer M, Raimundo K, Trzaskoma B, Solari PG, Antonova E, Mendelson M, Rosen KE. Angioedema in the omalizumab chronic idiopathic/spontaneous urticaria pivotal studies. Ann Allergy Asthma Immunol. 2016 Oct;117(4):370-377.e1. doi: 10.1016/j.anai.2016.06.024. Epub 2016 Jul 14. |
| 26054553 | Derived | Casale TB, Bernstein JA, Maurer M, Saini SS, Trzaskoma B, Chen H, Grattan CE, Gimenez-Arnau A, Kaplan AP, Rosen K. Similar Efficacy with Omalizumab in Chronic Idiopathic/Spontaneous Urticaria Despite Different Background Therapy. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):743-50.e1. doi: 10.1016/j.jaip.2015.04.015. Epub 2015 Jun 6. |
| 23432142 | Derived | Maurer M, Rosen K, Hsieh HJ, Saini S, Grattan C, Gimenez-Arnau A, Agarwal S, Doyle R, Canvin J, Kaplan A, Casale T. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med. 2013 Mar 7;368(10):924-35. doi: 10.1056/NEJMoa1215372. Epub 2013 Feb 24. |
| FG002 |
| Omalizumab 150 mg |
Omalizumab 150 mg sc every 4 weeks. |
| FG003 | Omalizumab 300 mg | Omalizumab 300 mg sc every 4 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified intent-to-treat population: All randomized patients who received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo administered subcutaneously (sc) every 4 weeks. |
| BG001 | Omalizumab 75 mg | Omalizumab 75 mg sc every 4 weeks. |
| BG002 | Omalizumab 150 mg | Omalizumab 150 mg sc every 4 weeks. |
| BG003 | Omalizumab 300 mg | Omalizumab 300 mg sc every 4 weeks. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Weekly Itch Severity Score at Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Urticaria Activity Score (UAS7) at Week 12 | The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Number of Hives Score at Week 12 | The weekly hives score is the sum of the daily hives scores over 7 days and ranges from 0 to 21. The number of hives is measured twice daily (morning and evening) on a scale of 0 (none) to 3 (> 12 hives per 12 hours). The daily hives score is the average of the morning and evening scores. The Baseline score is the sum of the daily hives scores over the 7 days prior to the first treatment. A higher score indicates more hives. A negative change score indicates improvement. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Minimally Important Difference (MID) Response in the Weekly Itch Severity Score by Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. The time to weekly itch severity score MID response was defined as the time (in weeks) from Day 1 to the study week when weekly itch severity score MID response was first achieved. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Median | 95% Confidence Interval | Weeks | by Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a UAS7 Less Than or Equal to 6 at Week 12 | The urticaria activity score (UAS) is a composite of scores on a scale of 0 (none) to 3 (intense/severe) for 1) the number of wheals (hives); and 2) the intensity of the itch, measured twice daily (morning and evening). Daily UAS is the average of morning and evening scores (ranging from 0-6) and the UAS7 is the sum of the daily UAS over 7 days (ranging from 0-42). Baseline UAS7 is calculated using data from the 7 days prior to the first treatment date. A higher UAS indicates more urticaria activity. A negative change score indicates improvement. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Number | Percentage of participants | Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Weekly Itch Severity Score MID Responders at Week 12 | The weekly itch severity score is the sum of the daily itch severity scores over 7 days and ranges from 0 to 21. The daily itch severity score is the average of the morning and evening scores on a scale of 0 (none) to 3 (severe). The Baseline weekly itch severity score is the sum of the daily itch severity scores over the 7 days prior to the first treatment. A higher itch severity score indicates more severe itching. A negative change score indicates improvement. The MID response for weekly itch severity score was defined as a reduction from baseline in weekly itch severity score of 5 points or more. This outcome measure shows the percentage of participants classified as MID Responders at Week 12, meaning their weekly itch severity scores at Week 12 were at least 5 points lower than at Baseline. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Number | Percentage of participants | Baseline, Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Weekly Size of the Largest Hive Score at Week 12 | The size of the largest hive is assessed twice daily (morning and evening) on a scale of 0 (none) to 3 (> 2.5 cm). The daily score is the average of the morning and evening scores. The weekly size of the largest hive score is the sum of the daily scores over 7 days, and ranges from 0 to 21. The Baseline weekly size of the largest hive score is the sum of daily scores over the 7 days prior to the first treatment. A higher score indicates larger hives. A negative change score indicates a reduction in hive size. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Overall Dermatology Life Quality Index (DLQI) at Week 12 | The dermatology life quality index (DLQI) is a 10-item dermatology-specific health-related quality of life measure. Participants rate their dermatology symptoms as well as the impact of their skin condition on various aspects of their lives on a scale of 0 (Not at all) to 3 (Very much). The overall DLQI is the sum of the responses to the 10 items and ranges from 0 to 30. A lower score indicates a better quality of life. A negative change score indicates improvement. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug and who had a DLQI score at Week 12. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Angioedema-free Days From Week 4 to Week 12 | The percentage of angioedema-free days from Weeks 4 to 12 was defined as the number of days a patient reported as angioedema-free in the daily diary divided by the total number of days with a non-missing diary entry, starting at the Week 4 visit and ending the day prior to the Week 12 visit. | Modified intent-to-treat population: All randomized patients who received at least one dose of study drug. Patients who withdrew before the Week 4 visit or who had missing responses for more than 40% of the daily diary entries between the Week 4 visit and the Week 12 visit were not included in the analysis. | Posted | Mean | Standard Deviation | Percentage of days | Week 4 to Week 12 |
|
Adverse events were collected from the date of first treatment through the end of the study (up to 28 weeks).
Safety evaluable set: All randomized participants who received at least one dose of study drug. Data are presented according to the doses actually received - one subject randomized to the 150 mg group withdrew before dosing, and six subjects randomized to the 75 mg group actually received 150 mg.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo administered subcutaneously (sc) every 4 weeks. | 2 | 79 | 35 | 79 | ||
| EG001 | Omalizumab 75 mg | Omalizumab 75 mg sc every 4 weeks. | 1 | 76 | 30 | 76 | ||
| EG002 | Omalizumab 150 mg | Omalizumab 150 mg sc every 4 weeks. | 1 | 88 | 42 | 88 | ||
| EG003 | Omalizumab 300 mg | Omalizumab 300 mg sc every 4 weeks. | 5 | 79 | 35 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhoids | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Tonsillectomy | Surgical and medical procedures | MedDRA (15.0) | Systematic Assessment |
| |
| Malignant melanoma in situ | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Idiopathic urticaria | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (15.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.0) | Systematic Assessment |
| |
| Idiopathic urticaria | Skin and subcutaneous tissue disorders | MedDRA (15.0) | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc | 800 821-8590 |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069444 | Omalizumab |
| ID | Term |
|---|---|
| D000888 | Antibodies, Anti-Idiotypic |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Male |
|
| The null hypothesis is that there is no difference between the placebo and omalizumab 150 mg groups. | ANCOVA | Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg). | 0.0011 | Refer to the Type-I error control plan. | Least Squares Mean Difference | -3.04 | 2-Sided | 95 | -4.85 | -1.24 | No | Superiority or Other |
| The null hypothesis is that there is no difference between the placebo and omalizumab 300 mg groups. | ANCOVA | Covariates included in the analysis were baseline weekly itch severity score (< 13 vs ≥ 13) and baseline weight (< 80 kg vs ≥ 80 kg). | <0.0001 | Refer to the Type-I error control plan. | Least Squares Mean Difference | -4.81 | 2-Sided | 95 | -6.49 | -3.13 | No | Superiority or Other |
Omalizumab 300 mg sc every 4 weeks. |
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Omalizumab 300 mg sc every 4 weeks
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Omalizumab 150 mg sc every 4 weeks
| OG003 | Omalizumab 300 mg | Omalizumab 300 mg sc every 4 weeks |
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Omalizumab 300 mg sc every 4 weeks |
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Omalizumab 150 mg sc every 4 weeks
| OG003 | Omalizumab 300 mg | Omalizumab 300 mg sc every 4 weeks |
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Omalizumab 300 mg sc every 4 weeks |
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Omalizumab 300 mg sc every 4 weeks |
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Omalizumab 300 mg sc every 4 weeks
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